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Cardiac Troponin I (cTnI) Test Kit (Fluorescence Immunochromatographic Assay)

EUDAMED

Class IVD General (EU MDR)

Ref /

by Shenzhen Reetoo Biotechnology Co., Ltd

Identity

Device Name
Cardiac Troponin I (cTnI) Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
Model / Reference
/ EUDAMED

Identifiers

Primary DI / UDI-DI
D-K90411-009PF EUDAMED
Basic UDI-DI
B-K90411-009PF EUDAMED
EMDN Code
W0102160703 TROPONIN I/T - RT & POC EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Cardiac Troponin I (cTnI) Test Kit (Fluorescence Immunochromatographic Assay) by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen Reetoo Biotechnology Co., Ltd
EUDAMED SRN
CN-MF-000011699
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED 27c1adf5-5286-4b8e-9432-29e99afd5819 61 fields · synced Oct 6, 2026